510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KFGClass I

Antiserum, Positive Control, Aspergillus Spp.

21 CFR 866.3040 / Microbiology
FDA source (opens on fda.gov)

KFG is the FDA product code for Antiserum, Positive Control, Aspergillus Spp., a class I device type, regulated under 21 CFR 866.3040. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KFG
Device name
Antiserum, Positive Control, Aspergillus Spp.
Regulation
21 CFR 866.3040
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code KFG

By decision year
5 clearances under product code KFG with a decision year between 1976 and 1991, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KFG by decision year
YearClearances
19761
19791
19802
19911

Applicants with the most clearances

Product code KFG
Applicants holding the most 510(k) clearances under product code KFG
ApplicantClearances
Meridian Diagnostics, Inc.2
Ackrad Laboratories1
I M, Inc.1
IMMY, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code